While the intellectual challenge of digital phenotyping (DP) has evolved from data collection to more complex data analysis (Onnela 2021), core ethical considerations remain centered on patient pri...

Given the need for enforceable guardrails for artificial intelligence (AI) that protect the public and allow for innovation, the U.S. Government recently issued a Blueprint for an AI Bill of Rights which outlines five principles of safe AI design, use, and implementation. One in particular, the right to notice and explanation, requires accurately informing the public about the use of AI that impacts them in ways that are easy to understand. Yet, in the healthcare setting, it is unclear what goal (...) the right to notice and explanation serves, and the moral importance of patient-level disclosure. We propose three normative functions of this right: (1) to notify patients about their care, (2) to educate patients and promote trust, and (3) to meet standards for informed consent. Additional clarity is needed to guide practices that respect the right to notice and explanation of AI in healthcare while providing meaningful benefits to patients. (shrink)

In their article “Implementing Expanded Prenatal Genetic Testing: Should Parents Have Access to Any and All Fetal Genetic Information?” Bayefsky and Berkman briefly mention that: “[s]ome are...

Integrating artificial intelligence (AI) into healthcare can potentially revolutionize how clinical decisions are made. Advancements in AI-driven Clinical Decision Support Systems (AI_CDSS) are enh...

Rapid advancements in artificial intelligence and machine learning (AI/ML) in healthcare raise pressing questions about how much users should trust AI/ML systems, particularly for high stakes clinical decision-making. Ensuring that user trust is properly calibrated to a tool’s computational capacities and limitations has both practical and ethical implications, given that overtrust or undertrust can influence over-reliance or under-reliance on algorithmic tools, with significant implications for patient safety and health outcomes. It is, thus, important to better understand how variability in trust (...) criteria across stakeholders, settings, tools and use cases may influence approaches to using AI/ML tools in real settings. As part of a 5-year, multi-institutional Agency for Health Care Research and Quality-funded study, we identify trust criteria for a survival prediction algorithm intended to support clinical decision-making for left ventricular assist device therapy, using semistructured interviews (n=40) with patients and physicians, analysed via thematic analysis. Findings suggest that physicians and patients share similar empirical considerations for trust, which were primarilyepistemicin nature, focused on accuracy and validity of AI/ML estimates. Trust evaluations considered the nature, integrity and relevance of training data rather than the computational nature of algorithms themselves, suggesting a need to distinguish ‘source’ from ‘functional’ explainability. To a lesser extent, trust criteria were also relational (endorsement from others) and sometimes based on personal beliefs and experience. We discuss implications for promoting appropriate and responsible trust calibration for clinical decision-making use AI/ML. (shrink)

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices to read and write shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, (...) no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to safety and security; enhancement as unnecessary, unnatural or aberrant; and fairness, equality, and distributive justice. Most researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening. However, researchers unanimously felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood. (shrink)

ChatGPT has taken the academic community by storm (Cotton, Cotton, and Shipway 2023; Cox and Tzoc 2023; Sullivan, Kelly, and McLaughlan 2023). Since its release in November 2022, chatGPT has predic...

ABSTRACT:Bioethicists today are taking a greater role in the design and implementation of emerging technologies by "embedding" within the development teams and providing their direct guidance and recommendations. Ideally, these collaborations allow ethical considerations to be addressed in an active, iterative, and ongoing process through regular exchanges between ethicists and members of the technological development team. This article discusses a challenge to this embedded ethics approach—namely, that bioethical guidance, even if embraced by the development team in theory, is not easily (...) actionable in situ. Many of the ethical problems at issue in emerging technologies are associated with preexisting structural, socioeconomic, and political factors, making compliance with ethical recommendations sometimes less a matter of choice and more a matter of feasibility. Moreover, incentive structures within these systemic factors maintain them against reform efforts. The authors recommend that embedded bioethicists utilize principles from behavioral science (such as behavioral economics) to better understand and account for these incentive structures so as to encourage the ethically responsible uptake of technological innovations. (shrink)

In their article, Cho and Martinez-Martin (2023) argue that developers and users of digital simulacra for modelling health and disease should involve a continued focus on causality of health states...

Frameworks for responsible data stewardship, such as that proposed by McCoy et al. (2023), are intended to encourage and provide guidelines for data processors to engage in responsible data process...

Volume 20, Issue 7, July 2020, Page 207-209.

Recent efforts in a range of scientific fields have emphasised research and methods concerning individual differences and individualisation. This article brings together various scientific disciplines—ecology, evolution, and animal behaviour; medicine and psychiatry; public health and sport/exercise science; sociology; psychology; economics and management science—and presents their research on individualisation. We then clarify the concept of individualisation as it appears in the disciplinary casework by distinguishing three kinds of individualisation studied in and across these disciplines: Individualisation ONE as creating/changing individual differences (the (...) process that generates differences between individuals: intrapopulation or intraspecific variation/heterogeneity); Individualisation TWO as individualising applications (the tailoring or customising of something—information, treatment, a product or service, etc.—for an individual or specific group of individuals); and Individualisation THREE as social changes influencing autonomy, risk, and responsibilities (the process discussed under the rubric of sociological individualisation theory). Moreover, we analyse conceptual links between individualisation and individuality, and characterise different sorts of individuality that the disciplines study. This paper aims to promote interdisciplinary research concerning individualisation by establishing a common conceptual-theoretical basis, while leaving room for disciplinary differences. (shrink)

The Commission on the Accreditation of Law Enforcement employs rigorous evaluation techniques. Objective accreditation, such as made possible by CALEA, is important from the public’s perspective and in the national community of law enforcement.To counteract a general distrust of law enforcement agencies, the Law Enforcement Assistance Administration developed a grant to develop standards by which the quality and performance of law enforcement could be measured. LEAA developed 107 standards and, though well received by the law enforcement community, no single group (...) or agency took the initiative to begin a program to evaluate and implement the standards. In 1979, the Department of Justice established an additional grant that effectively organized the four major law enforcement groups: the International Association of Chiefs of Police, the National Sheriff’s Association, the National Organization of Black Law Enforcement Executives, and the Police Executive Research Forum. (shrink)

In 2008, the Minister of Health for Iceland issued a new regulation intended to govern assessment practices related to placement in nursing homes. One of the aims of the regulation was to ensure that those with the most severe need would have priority. This would be achieved, in part, by requiring older people to exhaust all available community‐based service options before an assessment for placement would even take place. The new regulation was received with some hostility and criticism on the (...) part of older people and their relatives, who described the changed expectations as ‘abandonment’ by the authorities. We present our analysis of these changes by examining how older people and families are reconfigured through the new policy and argue that this ‘new’ practice of de‐institutionalization is underpinned by a shifting epistemic and normative context that is working to create a new identity and a different way of life in advanced age in Iceland. The analysis has implications for other nations as well, as much policy related to older people is broadly informed by this idea that ‘home is best’, that is, the idea that more care simply needs to happen outside of institutional settings. (shrink)

Volume 19, Issue 7, July 2019, Page 34-36.

This paper provides an analysis of nursing as a knowledgeable discipline. We examined ways in which knowledge operates in the practice of home care nursing and explored how knowledge might be fruitfully understood within the ambiguous spaces and competing temporalities characterizing contemporary healthcare services. Two popular metaphors of knowledge in nursing practice were identified and critically examined; evidence-based practice and the nurse as an intuitive worker. Pointing to faults in these conceptualizations, we suggest a different way of conceptualizing the relationship (...) between knowledge and practice, namely practice as being activated by contextualized knowledge. This conceptualization is captured in an understanding of the intelligent creation of context by the nurse for nursing practice to be ethical and effective. (shrink)

The application of machine learning in health care holds great promise for improving care. Indeed, our own team is collaborating with experts in machine learning and statistical modeling to bu...

The literature on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises concerns that these technologies may affect personality, mood, and behavior. We conducted semi-structured interviews with researchers (n = 23) involved in developing next-generation DBS systems, exploring their perspectives on ethics and policy topics including whether DBS/aDBS can cause such changes. The majority of researchers reported being aware of personality, mood, or behavioral (PMB) changes in recipients of DBS/aDBS. Researchers offered varying estimates of the frequency of PMB changes. A (...) smaller majority reported changes in personality specifically. Some expressed reservations about the scientific status of the term ‘personality,’ while others used it freely. Most researchers discussed negative PMB changes, but a majority said that DBS/aDBS can also result in positive changes. Several researchers viewed positive PMB changes as part of the therapeutic goal in psychiatric applications of DBS/aDBS. Finally, several discussed potential causes of PMB changes other than the device itself. (shrink)

Background Deep brain stimulation is approved for treating refractory obsessive-compulsive disorder in adults under the US Food and Drug Administration Humanitarian Device Exemption, and studies have shown its efficacy in reducing symptom severity and improving quality of life. While similar deep brain stimulation treatment is available for pediatric patients with dystonia, it is not yet available for pediatric patients with obsessive-compulsive disorder, although soon could be. The prospect of growing indications for pediatric deep brain stimulation raises several ethical concerns relating (...) to bodily integrity, the ability to offer informed assent, and the role pediatric patients play in the decision-making process. Objective The aim of this study is to solicit and assess the views of stakeholders (children, parents, clinicians) on pediatric assent, autonomy, and bodily integrity in the context of potential pediatric deep brain stimulation for obsessive-compulsive disorder. Methods Semi-structured interviews were conducted with pediatric obsessive-compulsive disorder patients ( n = 21), caregivers of pediatric obsessive-compulsive disorder patients aged 14–18 ( n = 19), and clinicians with experience treating refractory obsessive-compulsive disorder ( n = 25). Interviews were transcribed and coded in MAXQDA 2018 and 2020 software and processed for thematic content analysis to isolate and compare specific themes. Results A majority of respondents (74%, 48/65) across all three stakeholder groups voiced that the decision-making process should be collaborative and involve everyone (clinicians: 84% or 21/25, caregivers 71% or 15/21, and patients 63% or 12/19). We identified a split between respondents’ views on who should have the final say in the event of disagreement (38% or 25/65 favored the patient versus 35% or 23/65 favoring caregivers). A split between respondents also emerged concerning the maturity relevant for deep brain stimulation decision-making, with 45% (29/65) favoring developmental maturity (age/physiological development) and 45% (29/65) favoring decisional maturity (capacity to understand and weigh information). A majority of clinicians indicated that they would not move forward with deep brain stimulation without securing patient assent (80% or 20/25), with some stating the only exception is if patient quality of life was very poor and/or they lacked insight. Both caregivers and patients expressed a significant respect for the patient's right to bodily integrity, with 67% of caregivers (14/21) and 68% of patients (13/19) justifying patient involvement in decision-making specifically with reference to infringements of bodily integrity. Conclusion Our findings demonstrate that despite broad agreement across stakeholders that the decision-making process for pediatric deep brain stimulation for obsessive-compulsive disorder should be collaborative and somehow involve pediatric patients, there is disagreement about what this process entails and what factors determine patient involvement in the process. However, there is agreement that children have a right to bodily and brain integrity, which should only be infringed upon in rare circumstances. (shrink)

Introduction Deep brain stimulation (DBS) is approved under a humanitarian device exemption to manage treatment-resistant obsessive-compulsive disorder (TR-OCD) in adults. It is possible that DBS may be trialed or used clinically off-label in children and adolescents with TR-OCD in the future. DBS is already used to manage treatment-resistant childhood dystonia. Evidence suggests it is a safe and effective intervention for certain types of dystonia. Important questions remain unanswered about the use of DBS in children and adolescents with TR-OCD, including whether (...) mental health clinicians would refer pediatric patients for DBS, and who would be a good candidate for DBS.Objectives To explore mental health clinicians’ views on what clinical and psychosocial factors they would consider when determining which children with OCD would be good DBS candidates.Materials and Methods In depth, semi-structured interviews were conducted with n = 25 mental health clinicians who treat pediatric patients with OCD. The interviews were transcribed, coded, and analyzed using thematic content analysis. Three questions focused on key, clinical, and psychosocial factors for assessing candidacy were analyzed to explore respondent views on candidacy factors. Our analysis details nine overarching themes expressed by clinicians, namely the patient’s previous OCD treatment, OCD severity, motivation to commit to treatment, presence of comorbid conditions, family environment, education on DBS, quality of life, accessibility to treatment, and patient age and maturity.Conclusions Clinicians generally saw considering DBS treatment in youth as a last resort and only for very specific cases. DBS referral was predominantly viewed as acceptable for children with severe TR-OCD who have undertaken intensive, appropriate treatment without success, whose OCD has significantly reduced their quality of life, and who exhibit strong motivation to continue treatment given the right environment. Appropriate safeguards, eligibility criteria, and procedures should be discussed and identified before DBS for childhood TR-OCD becomes practice. (shrink)

BackgroundIn the context of limited health care budgets in countries where Neglected Tropical Diseases (NTDs) are endemic, scaling up disease control interventions entails the setting of priorities. However, solutions based solely on cost‐effectiveness analyses may lead to biased and insufficiently justified priorities.ObjectivesThe objectives of this paper are to 1) demonstrate how a range of equity concerns can be used to identify feasible priority setting criteria, 2) show how these criteria can be fed into a multi‐criteria decision‐making matrix, and 3) discuss (...) the conditions under which this decision‐making procedure should be carried out in a real‐world decision‐making context.MethodsThis paper draws on elements from theories of decision analysis and ethical theories of fair resource allocation. We explore six typical NTD interventions by employing a modified multi‐criteria decision analysis model with predefined criteria, drawn from a priority setting guide under development by the WHO. To identify relevant evidence for the six chosen interventions, we searched the PubMed and Cochrane databases.DiscussionOur in vitro multi‐criteria decision analysis suggested that case management for visceral leishmaniasis should be given a higher priority than mass campaigns to prevent soil‐transmitted helminthic infections. This seems to contradict current health care priorities and recommendations in the literature. We also consider procedural conditions that should be met in a contextualised decision‐making process and we stress the limitations of this study exercise.ConclusionBy exploring how several criteria relevant to the multi‐facetted characteristics of NTDs can be taken into account simultaneously, we are able to suggest how improved priority settings among NTDs can be realised. (shrink)

Researchers and practitioners are increasingly using machine-generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood (...) to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

Background: A limited number of studies have shown that patient advocacy can be influenced by both facilitators and barriers which can encourage and discourage nurses to act as patient advocates. Objective: This study’s aim was to describe Swedish nurses’ perceptions of influencers on patient advocacy. Research design and context: Interviews with 18 registered nurses from different Swedish clinical contexts were analysed using the phenomenographic method. Ethical considerations: Ethical revisions were made in accordance with national legislation and guidelines by committees for (...) research ethics at Karlstad University. Findings: Three levels of hierarchically related influencers on patient advocacy were found in the descriptive categories. The fundamental influencer, the nurse’s character traits, was described in the perceptions that advocacy is influenced by nurse’s having a moral compass, having control over the care situation, being protective and feeling secure as a nurse. The second most vital influencer, the nurse’s bond with the patient, was expressed in the perceptions of knowing the patient and feeling empathy for the patient. The third level of influencers, the organisational conditions, was described in the perceptions that the organisational structures and organisational culture influence patient advocacy. Discussion: The results correspond with findings from earlier research but add an understanding that influencers on patient advocacy exist at three hierarchically related levels. Conclusion: The nurse’s character traits are the fundamental influencer to patient advocacy, but in order to be comfortable and secure when advocating for patients, nurses also need to be familiar with both the patient and the situation. A supposition could be that all influencers interact, which needs to be further addressed in future studies. (shrink)

Researchers and practitioners are increasingly using machine‐generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood (...) to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data (...) or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research. (shrink)

The ongoing debate within neuroethics concerning the degree to which neuromodulation such as deep brain stimulation (DBS) changes the personality, identity, and agency (PIA) of patients has paid relatively little attention to the perspectives of prospective patients. Even less attention has been given to pediatric populations. To understand patients’ views about identity changes due to DBS in obsessive-compulsive disorder (OCD), the authors conducted and analyzed semistructured interviews with adolescent patients with OCD and their parents/caregivers. Patients were asked about projected impacts (...) to PIA generally due to DBS. All patient respondents and half of caregivers reported that DBS would impact patient self-identity in significant ways. For example, many patients expressed how DBS could positively impact identity by allowing them to explore their identities free from OCD. Others voiced concerns that DBS-related resolution of OCD might negatively impact patient agency and authenticity. Half of patients expressed that DBS may positively facilitate social access through relieving symptoms, while half indicated that DBS could increase social stigma. These views give insights into how to approach decision-making and informed consent if DBS for OCD becomes available for adolescents. They also offer insights into adolescent experiences of disability identity and “normalcy” in the context of OCD. (shrink)

Background In the context of limited health care budgets in countries where Neglected Tropical Diseases are endemic, scaling up disease control interventions entails the setting of priorities. However, solutions based solely on cost-effectiveness analyses may lead to biased and insufficiently justified priorities. Objectives The objectives of this paper are to 1) demonstrate how a range of equity concerns can be used to identify feasible priority setting criteria, 2) show how these criteria can be fed into a multi-criteria decision-making matrix, and (...) 3) discuss the conditions under which this decision-making procedure should be carried out in a real-world decision-making context. Methods This paper draws on elements from theories of decision analysis and ethical theories of fair resource allocation. We explore six typical NTD interventions by employing a modified multi-criteria decision analysis model with predefined criteria, drawn from a priority setting guide under development by the WHO. To identify relevant evidence for the six chosen interventions, we searched the PubMed and Cochrane databases. Discussion Our in vitro multi-criteria decision analysis suggested that case management for visceral leishmaniasis should be given a higher priority than mass campaigns to prevent soil-transmitted helminthic infections. This seems to contradict current health care priorities and recommendations in the literature. We also consider procedural conditions that should be met in a contextualised decision-making process and we stress the limitations of this study exercise. Conclusion By exploring how several criteria relevant to the multi-facetted characteristics of NTDs can be taken into account simultaneously, we are able to suggest how improved priority settings among NTDs can be realised. (shrink)

IntroductionDeep brain stimulation (DBS) is utilized to treat pediatric refractory dystonia and its use in pediatric patients is expected to grow. One important question concerns the impact of hope and unrealistic optimism on decision-making, especially in “last resort” intervention scenarios such as DBS for refractory conditions.ObjectiveThis study examined stakeholder experiences and perspectives on hope and unrealistic optimism in the context of decision-making about DBS for childhood dystonia and provides insights for clinicians seeking to implement effective communication strategies.Materials and MethodsSemi-structured interviews (...) with clinicians (n = 29) and caregivers (n = 44) were conducted, transcribed, and coded.ResultsUsing thematic content analysis, four major themes from clinician interviews and five major themes from caregiver interviews related to hopes and expectations were identified. Clinicians expressed concerns about caregiver false hopes (86%, 25/29) and desperation (68.9%, 20/29) in light of DBS being a last resort. As a result, 68.9% of clinicians (20/29) expressed that they intentionally tried to lower caregiver expectations about DBS outcomes. Clinicians also expressed concern that, on the flip side, unrealistic pessimism drives away some patients who might otherwise benefit from DBS (34.5%, 10/29). Caregivers viewed DBS as the last option that they had to try (61.3%, 27/44), and 73% of caregivers (32/44) viewed themselves as having high hopes but reasonable expectations. Fewer than half (43%, 19/44) expressed that they struggled setting outcome expectations due to the uncertainty of DBS, and 50% of post-DBS caregivers (14/28) expressed some negative feelings post treatment due to unmet expectations. 43% of caregivers (19/44) had experiences with clinicians who tried to set low expectations about the potential benefits of DBS.ConclusionThoughtful clinician-stakeholder discussion is needed to ensure realistic outcome expectations. (shrink)

Book reviewed in this article: Abortion and Woman's Choice: The State, Sexuality, and Reproductive Freedom. By Rosalind P. Petchesky. Abortion and the Politics of Motherhood. By Kristin Luker.

Ellen Gleditsch (1879–1968) became Norway’s first authority on radioactivity and the country’s second female full professor. From her many years abroad—in Marie Curie’s laboratory in Paris and at Yale University in New Haven with Bertram Boltram—she became internationally acknowledged and developed an extensive personal and scientific network. In the Norwegian scientific community she was, however, less appreciated, and her appointment as a professor in 1929 caused controversy. Despite the recommendation of the expert committee, her predecessor and his allies spread (...) the view that Gleditsch was a diligent but outdated researcher with little scientific promise—a view that apparently persists in the Norwegian chemical community today. In addition to her scientific work, Gleditsch acquired political influence by joining the International Federation of University Women in 1920; she later became the president of both the Norwegian section and the worldwide organization. She worked in particular to establish scholarships enabling women to go abroad. I once worked with a learned man who was reputed to hate women. On one occasion he stated that the new collaborator was a rare exception. When he was asked why he said, “She does not scream.” I heard this several months later and have kept it as a great compliment; yes—the biggest in my scientific career. —Ellen Gleditsch. (shrink)